Diagnostic specimen mailing device

ABSTRACT

A mailing device for etiologic agents and/or biomedical materials is disclosed. The mailing device comprises a front panel joined to a back panel, the back panel being longer than the front panel. Three sides of each panel are sealed together, preferably by an adhesive, most preferably by heat sealing, such that an opening to an internal region is created, said opening defined by the top, unsealed portion of the front panel, and the top unsealed portion of the back panel which exceeds the height of the front panel. The region of the back panel extending above that of the front panel is referred to as a &#34;flap&#34; or &#34;flap region&#34;. The flap region includes means for folding the flap along a substantially parallel line to said opening, said line being located above the opening, preferably from between about one-fourth to about one-half of the distance of the flap upwards from said opening and most preferably about one-fourth of the distance of said flap upward from said opening. The flap of the device further includes at least one tab extending outwardly therefrom such that when the flap is folded and sealed, the tab can similarly be folded and sealed to either the front panel or the back panel so as to provide an added measure of security.

This is a continuation of application Ser. No. 07/622,677, filed Dec. 7,1990, now abandoned.

FIELD OF THE INVENTION

The present invention is related to mailing envelopes and moreparticularly to mailing envelopes for diagnostic specimens.

BACKGROUND OF THE INVENTION

The advent of patient-friendly specimen collection test devices hasallowed patients to obtain certain etiologic agents and/or biomedicalmaterials (such as, for example, fecal specimens) in the privacy of thepatient's home, advantageously avoiding embarrassment, discomfort andanxiety for not only the patient, but those in the medical professionthat require such specimens for analysis. For example, fecal occultblood screening for an indication of the possibility of colon cancernecessitates examination of a fecal specimen from the patient--severaltest devices are available that allow the patient to incorporate a fecalspecimen onto the device such that analysis thereof can be performed ata later time by a healthcare professional.

One problem associated with such devices, however, is that despite theability to utilize these in a non-medical facility (for example, thepatient's home), the patient is usually required to make a special tripto return the device to the healthcare professional for testing thereof.Because the test device can be used, e.g., in the privacy of thepatient's home and must be returned to a healthcare professional, it isevident that delivery of the test device via the services of a postalcarrier service, for example, the United States Postal Service, wouldmake the return of the test device more convenient for the patient.

Governmental regulations may, and often do, restrict the mailing ofetiologic agents and/or biomedical materials due to the potential harmfrom spills and leakages of such materials. In the United States ofAmerica, strict regulations are set forth for the mailing of suchspecimens. See, 39 C.F.R., Federal Register, Part 111, Vol. 54, No. 156(Aug. 1989) which is incorporated herein by reference. Aside from suchhazardous concerns, certain aesthetic concerns are of similar import,such as, for example, negative odors that may offend those who arerequired to transport such materials through the mails. Furthermore,because such a mailing device necessarily transports specimens fordiagnostic evaluation, it is also essential that the mailing deviceprevent contaminants from outside the mailing device from contacting thespecimen included therein.

Given the routine nature of use of the types of such specimen devicesdescribed above, the costs associated with a specimen mailing device cannot be prohibitively expensive such that the cost of such a mailingdevice would outweigh the above noted benefits. Traditional mailingdevices are relatively inexpensive. However, such devices include anopening to be sealed by folding a flap along the opening itself--thistype of folding can allow for leakage of the contents of the device fromthe corners of the insertion region. Such a device is in completecontradistinction to the needs of a specimen mailing device thatmandates prevention of even the possibility of such leakage.

Accordingly, a need exists for a mailing device for etiologic agentsand/or biomedical materials that takes into account not onlygovernmental regulations, but also the sensibilities of those that musthandle and process such a device as well as the cost relevant factorsnoted above. Finally, and because such a device will necessarily findapplicability across a broad spectrum of patients, it is important forsuch a device to be easily manipulated when used.

SUMMARY OF THE INVENTION

A mailing device that complies with and satisfies the above-listedrequirements and concerns is disclosed herein.

In an embodiment, the mailing device comprises a front panel joined to aback panel, the back panel being longer than the front panel. Threesides of each panel are sealed together, preferably by an adhesive, mostpreferably by heat sealing, such that an opening to an internal regionis created, the opening defined by the top, unsealed portion of thefront panel, and the top unsealed portion of the back panel.Additionally, the height of the back panel exceeds the height of thefront panel. The region of the back panel extending above that of thefront panel is referred to herein as a "flap" or "flap region". The flapregion includes means for folding the flap along a substantiallyparallel line to said opening, the line being located above the opening,preferably from between about one-fourth to about one-half of thedistance of the flap upwards from the opening and most preferably aboutone-fourth of the distance of the flap upwards from said opening. Inthis manner, and because the flap is not folded along the pouch opening,leakage out from or into the pouch is avoided. The flap of the devicefurther includes at least one tab, preferably two, extending outwardlyfrom the flap that when the flap is folded and sealed, the tab cansimilarly be folded and sealed to provide an added measure of security.

Other advantages of the present invention will be made apparent as thedescription proceeds.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the mailing device ofthe present application, in an open position;

FIG. 2 is the same perspective view of the device of FIG. 1 with theflap sealed;

FIG. 3 is the same perspective view of the device of FIG. 2 having oneof the two tabs sealed.

FIG. 4 is a side view of an embodiment of the mailing device of thepresent application including an additional interior barrier.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to FIG. 1-3 of the preferred embodiment of the inventionand where identical numbers designate identical features, a specimenmailing device 100 is depicted. The device is preferably formed of asingle sheet, having front panel 101a and back panel 101b folded alongcrease 103 where sides 105 and 107 are securely sealed by any suitablesealing method, such as by an adhesive, glue, or, preferably in thedisclosed embodiment, heat sealing. A single sheet is preferred in thatsealing along crease 103 would not be essential; however, two separatesheets may be utilized, whereby a side corresponding to crease 103 wouldbe sealed in a manner analogous to that used in the sealing of sides 105and 107.

Referring now to the region of device 100 opposite to crease 103, testdevice insertion region 115 is defined by the termination of front panel101a and the continuation of back panel 101b, whereby a pocket or pouchregion is formed, generally being defined as the entire interior regionbetween sides 105, 107, crease 103 and insertion region 115. A flap 109is defined by the extension of back panel 101b from insertion region 115to the termination of back panel 101b, and includes means for indicatingthe closing off and sealing of insertion region 115. As an example of ameans for indicating, crease 120, located about one-fourth of thedistance of flap 109 upwards from insertion region 115, defines the areaof flap 109 that is folded to secure an etiologic agent and/orbiomedical material (not shown) which has been inserted into the pouchregion of mailing device 100. Alternative means for indicating theclosing off and sealing insertion region 115 include, for example,instructions informing the user to fold flap 109 at a point aboveinsertion region 115, or hash-mark indicators located at aboutone-fourth to about one-half of the distance upwards from insertionregion 115 and most preferably beginning at about one fourth thedistance upwards from insertion region 115.

FIG. 2 shows device 100 having flap 109 folded along crease 120 and insecure contact with the upper region of side 101a. As best viewed inFIG. 2, by folding flap 109 along crease region 120, specimen deviceinsertion region 115 (shown from a cut-away of flap 109) isadvantageously located below crease 120 and above a reference line 500(shown in phantom) where flap 109 and front panel 101a are approximatelyjoined. This folding configuration negates the risk of leakage out fromor into region 115 in that region 115 is covered and sealed. Suchsealing is preferably effectuated by incorporation of an adhesive 130 onflap 109 and a region 119 between the termination of front panel 101aand crease region 120. Thus, when flap 109 is closed, adhesive 130secures flap 109 to both region 119 and from reference line 500 up toinsertion region 115. As an alternative to the use of an adhesive,sealing materials, such as, for example, an adhesive tape, can beapplied to flap 109 when it is in its closed position so that sealingthereof to front panel 101a is similarly effectuated.

Device 100 further includes tabs 111 and 113 extending outwardly fromflap 109 in a direction perpendicular to flap 109. Tabs 111 and 113include means for folding these so as to engage the exterior region ofside 101b (not shown). Most preferably, such means for folding arepre-formed creases as defined by lines 112 and 114, respectively. Tabs111 and 113 also preferably include thereon adhesive 130. ReferencingFIG. 3, when flap 109 is folded along crease 120 to a closed position,both tabs are folded inwardly to contact the exterior region of side101b (not shown). FIG. 3 shows tab 111 in a closed position, foldedalong crease 112, with the outer edge 111a (shown in cut-away) of tab111 perpendicular to crease 120. The cut-away of FIG. 3 also showsinsertion region 115 approximately bisecting tab 111. Thus, when bothflap 109 and tabs 111 and 113 are in a closed position, insertion region115 is completely sealed such that leakage from within is prevented, andcontamination from outside influence is also prevented.

Preferably, device 100 is die cut from a single sheet so that flap 109,tabs 111 and 113, crease 120, and creases 112 and 114 are formed duringthe die-cutting process. As best viewed in FIG. 4 the single sheetincludes at least three layers: a first layer 310 (i.e. the outer layer)can be paper or cardboard; a second layer 320 (i.e. the middle layer)can be a metallic foil or metallized polymeric material; and a thirdlayer 330 (i.e. the interior layer) can be a thin layer of polyethyleneor polypropylene laminated thereon to seal the second layer to thefirst. Three layers are preferred because the middle layer, which can besealed to the outer layer by the interior layer, acts as a "primarybarrier" against leakage of the etiological and/or biomedical materialsthrough the outer layer if such material begins to leak from the pouchregion. Accordingly, metallic foils (such as aluminum) and metallizedpolymeric materials are most preferred for the middle layer because suchmaterials prevent such leakage. Paper or cardboard materials are mostpreferred for the outer layer in that these can be readily pre-printedwith information typically imprinted on mailing envelopes (i.e. postagestamp location, return address information, as well as any pertinentinstructions). Polyethylene and polypropylene are most preferred for thethird layer in that these materials are useful in a heat-sealing processbecause these materials, by their very nature, will form a sealed bondupon heating.

A layer of adhesive 130, as previously detailed, is preferably addedonto the third layer and can begin directly above insertion region 115,covering flap 109, tabs 111 and 113 and region 119. A removableprotective tape (not shown) is preferably included on the adhesive 130.When completed, the mailing device can have mailing information printedon sides 101a or 101b, as well as any other pertinent and/or additionalinformation.

An additional layer or barrier 340 can be layered on top of the thirdlayer such that when the device is fully constructed, the interiorregion between sides 105, 107, crease 103 and insertion region 115 (FIG.1-3) is defined between layer 340. Layer 340 can be either a singlesheet such that the single sheet is folded when crease 103 is formed, ortwo sheets. In either case, when sides 105 and 107 are sealed, layer 340is similarly sealed. Thus, layer 340 forms a "pocket" within theembodiment disclosed in FIG. 1-3. Layer 340 is preferably a flexiblematerial that is liquid impermeable; layer 340 is primarily intended toact as additional security against any potential leakage from anetiologic agent and/or biomedical material inserted into the device.Flexibility is preferred for the additional barrier primarily formanufacturing concerns in that if the additional barrier is too thick(i.e. not flexible), manipulation of the device during the manufacturingprocess is made unnecessarily difficult. Layer 340 can be sealed to theinterior layer by either an adhesive joining layer 340 to the interiorlayer, or by heat sealing in a manner previously described. Becauselayer 340 is preferably flexible and water impermeable, it can beselected from a group consisting of polyvinyl chlorides, polyesters,polycarbonates, polyethylene, and multi-polymeric materials, such as,for example, paper coated with any of the above listed materials. Mostpreferably, the thickness of layer 340 is between about 2 and about 15mils (1 mil=0.001 inch). Such a thickness range is most preferredbecause it provides sufficient flexibility for layer 340.

To use the device, a specimen collection device including an etiologicagent and/or biomedical material is inserted into the interior portionof mailing device 100 at insertion region 115. A protective tape (notshown) covering adhesive 130 is removed, and flap 109 is folded alongcrease 120 such that flap 109 securely seals insertion region 115.Thereafter, tabs 111 and 113 are folded along creases 112 and 114,respectively, such that when completed, tabs 111 and 113 are in contactwith the exterior portion of side 101b (not shown). Mailing of thedevice is then accomplished in a manner as defined by the rules andrequirements for utilization of the applicable postal service. Whenreceived by the healthcare professional, the test device can be removedby cutting or tearing open the mailing device along any edge.

While the foregoing mailing device has been described in considerabledetail and in terms of preferred embodiments, these are not to beconstrued as limitations on the disclosure or the claims that follow.Modifications and changes that are within the purview of those skilledin the art are intended to fall within the scope of the followingclaims.

What is claimed is:
 1. A mailing device useful for etiologic agents andbiomedical materials comprising:a) a substantially rectangular frontpanel and a substantially rectangular back panel where three sides ofsaid front panel and three sides of said back panel are in sealedcommunication with each other, said sealed sides being impervious toliquids, and where a fourth side of said front panel and a fourth sideof said back panel define an opening to an interior central regionbetween said front panel and said back panel, said front panel and saidback panel each comprising at least two layers, a first outer layer anda second interior layer, said second interior layer being exposed tosaid interior central region, said second interior layer beingimpervious to liquids, said second interior layer being chemically inertto etiologic agents and biomedical materials, the side of said backpanel not in sealed communication with the side of said front panelfurther comprising a flap region, said flap region defining a firstlength, said flap region comprising: i) adhesive means for sealing saidflap region to said front panel; ii) means for folding said flap region,said means being located along a line substantially parallel to saidopening to said interior central region, said line being from aboutone-fourth to about one-half of the length of said flap region from saidopening to said interior central region; and iii) at least two tabs, afirst tab extending outwardly from said flap region in a directionparallel to the opening of said interior central region, and a secondtab extending outwardly from said flap region in a direction parallel tothe opening of said interior central region, said first tab and saidsecond tab being on opposite ends of said flap region relative to eachother, said first tab and said second tab each including means forfolding said tabs, said first tab and said second tab each includingadhesive means for sealing said tabs to said back panel.
 2. The deviceof claim 1 wherein said means for folding said tabs is a crease in eachtab.
 3. The device of claim 1 wherein said first outer layer is amaterial chosen from the group consisting of paper and cardboard.
 4. Thedevice of claim 1 wherein said second, interior layer is a materialchosen from the group consisting of polyethylenes and polypropylenes. 5.The device of claim 1 wherein said front and back panels each furthercomprise a third middle layer between said first outer layer and saidsecond interior layer.
 6. The device of claim 5 wherein said thirdmiddle layer is a material chosen from the group consisting of metallicfoils and metallized polymeric materials.
 7. The device of claim 5wherein said third, middle layer is an aluminum foil material.
 8. Thedevice of claim 5 wherein said front and back panels each furthercomprise an additional layer overlying said second interior layer saidadditional layer being impervious to liquids and chemically inert, toetiologic agents and biological materials.
 9. The device of claim 8wherein said additional layer is a material chosen from the groupconsisting of polyvinyl chlorides, polyesters, polycarbonates,polyethylenes, and paper or cardboard coated with polyvinyl chlorides,polyesters, polycarbonates or polyethylenes.
 10. The device of claim 8wherein the thickness of said additional layer is between about 2 andabout 15 mils.